Journal Article Ahead of print
PubMed: 42647052 DOI: 10.1002/ohn.70406
Efficacy of Exhalation Delivery System With Fluticasone in Chronic Rhinosinusitis With Versus Without Polyps.
Otolaryngol Head Neck Surg
Authors: Rodney J Schlosser, Nithin D Adappa, Rakesh K Chandra, Greg E Davis, Mahboobeh Mahdavinia, John Messina, Zara M Patel, Anju T Peters, Raj Sindwani, Zachary M Soler, Andrew A White, Sarah K Wise, James N Palmer
Affiliations
- Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
- Department of Otorhinolaryngology - Head and Neck Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
- Department of Otolaryngology - Head and Neck Surgery, University of Mississippi Medical Center, Jackson, Mississippi, USA.
- Ear Nose Throat and Allergy Associates, Proliance Surgeons, Seattle and Puyallup, Seattle, Washington, USA.
- Division of Allergy & Immunology, UT Health Houston, Houston, Texas, USA.
- Clinical Research and Medical Affairs, Optinose US, Inc, Yardley, Pennsylvania, USA.
- Department of Otolaryngology - Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.
- Division of Allergy and Immunology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
- Head and Neck Surgery Department, Integrated Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA.
- Division of Allergy, Asthma and Immunology, Scripps Clinic, San Diego, California, USA.
- Department of Otolaryngology-Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Abstract
OBJECTIVE
To evaluate whether treatment responses to the exhalation delivery system with fluticasone (EDS-FLU; XHANCE®) differ between patients with CRS with nasal polyps (CRSwNP) and patients without nasal polyps (CRSsNP).
STUDY DESIGN
Post hoc analysis of the ReOpen clinical trials conducted between November 2018 and November 2021 for a 24-week duration.
SETTING
Multinational, multicenter, randomized, EDS-placebo-controlled studies.
METHODS
Data were pooled from the randomized trials in which patients with CRSwNP (n = 206) or CRSsNP (n = 341) were randomly assigned (1:1:1) to EDS-FLU 186 μg, 372 μg, or EDS-placebo, 1 or 2 sprays twice daily per nostril for 24 weeks. Endpoints included composite symptom score, Smell Identification Test (SIT), sinus opacification on computed tomography (CT) scan, frequency of acute exacerbations of CRS, 22-Item Sino-Nasal Outcome Test (SNOT-22), and Patient Global Impression of Change (PGIC).
RESULTS
Patients with CRSwNP and CRSsNP reported substantially greater benefits with EDS-FLU versus EDS-placebo on symptoms, SIT, sinus opacification on CT scan, incidence of acute exacerbations of CRS, and quality-of-life outcomes (SNOT-22 and PGIC). Composite symptom score and SNOT-22 improvements were consistent in the subgroup of patients entering the trial reporting symptoms despite recent standard-delivery nasal steroid spray use. Treatment-by-subgroup interaction effects indicated similar magnitude EDS-FLU treatment effect for patients with CRSwNP and patients with CRSsNP.
CONCLUSION
EDS-FLU improved subjective and objective measures of CRS irrespective of nasal polyp status.
TRIAL REGISTRATION
Title: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps; ID: NCT03781804 and NCT03960580, Clinicaltrials.gov.
MeSH
Exhalation, Smell, Fluticasone, Polyps, Signs And Symptoms, Therapeutics, Nasal Polyps, Rhinosinusitis